CompletedNot Applicable

Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients?

United States30 participantsStarted 2022-07-06

Plain-language summary

Participants will be recruited by performing chart reviews of patients to be seen at University of Texas Medical Branch at Galveston Ophthalmology and Optometry Clinic. A sample size of at least 30 patients is needed (60 eyes). Patients aged 55 and higher will be further evaluated to meet the inclusion criteria. Patients meeting inclusion criteria will be provided with informed consent to participate in the study before their office visit. Patients will receive a consent briefing then asked to sign and date the informed consent form. Participants will then be randomized to undergo an eye exam and refractive exam with noise cancelling Bluetooth headphones for one eye and without for the other eye. Participants will fill out a written survey asking them to rate the quality of the eye exam with and without headphones. Primary aim: Assess the quality improvement of Ophthalmic exam in geriatric patients with hearing loss with use of noise cancelling headphones with Bluetooth feature. Secondary aims: 1)Compare the response to the standardized questions with and without Bluetooth noise cancelling headphones to determine their effectiveness in conducting Ophthalmic refractive exam. 2\) Explore the ease of conducting refractive exam as reported by provider.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants are patients of University of Texas Medical Branch Ophthalmology and Optical clinics; * patients of investigators; * aged 55 years and above; * participants with moderate hearing impairment or worse at baseline hearing grade of limited or impaired based on World Health Organization (WHO) hearing loss guidelines; * participants with documented history of hearing loss; * participants with no corrective procedures performed for hearing loss. Exclusion Criteria: * Participants with mild to no hearing impairment at baseline reported as hearing grade fair, good or excellent on the Sound-Check hearing test; * participants with history of corrective procedure performed for hearing loss; * participants with cognitive impairment; * participants with visual impairment of best corrected visual acuity (BCVA) 20/100 or worse in either eye or patients with monocular vision; * participants from vulnerable populations, such as prisoners.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Do Bluetooth Noise Cancelling Headphones Improve the Quality of Care in Hearing Impaired Patients?

Timeframe: 8 months

Trial details

NCT IDNCT05420038

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-19

View on ClinicalTrials.gov More Hearing Impairment trials